市販後のセレクト プラチナ大静脈フィルターとギュンター チューリップ回収セットの研究
市販後のセレクトプラチナ大静脈フィルターとギュンターチューリップ回収セットの研究
This prospective, observational, post-market study will be performed to collect patient-level data on the Celect Platinum Vena Cava Filter Sets and the Günther Tulip Vena Cava Filter Retrieval Set to confirm continued safety and performance of the devices throughout their expected lifetime and continued acceptability of the benefit:risk ratio. Additionally, the study intends to evaluate longer-term (i.e., up to 5 years) outcome data while the filter is indwelling.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Sabina Andersen
- 電話番号：+45 29 73 41 34
- メール：sabina.hjorth@cookmedical.com
研究場所
-
-
California
-
Los Angeles、California、アメリカ、90048
- 募集
- Cedars-Sinai Medical Center
-
-
-
-
-
Hull、イギリス、HU3 2JZ
- 募集
- Hull University Teaching Hospitals NHS Trust
-
Liverpool、イギリス、L7 8XP
- 募集
- Royal Liverpool Hospital
-
-
West Yorkshire
-
Leeds、West Yorkshire、イギリス、LS1 3EX
- 募集
- Leeds Teaching Hospital NHS Trust
-
-
-
-
-
Barcelona、スペイン、08907
- 募集
- Hospital Universitari de Bellvitage
-
Córdoba、スペイン、14004
- 募集
- Hospital Reina Sofia de Cordoba
-
Sabadell、スペイン、08208
- 募集
- Parc Tauli
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
A patient dataset is deemed suitable for inclusion in the study if the patient has a procedure where a Celect Platinum Vena Cava Filter
説明
Inclusion Criteria:
- A patient dataset is deemed suitable for inclusion if the patient has a procedure where a Celect Platinum Vena Cava Filter is placed
- Subject has not previously participated in the Cook MDR-2126 study.
Exclusion Criteria:
- Patients will be excluded from enrollment if the patient or his/her legally authorized representative objects to collection and processing of his/her data or is not willing to sign the Informed Consent.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Patients indicated for the placement of a Celect Platinum Vena Cava Filter
Patients indicated for the placement of a Celect Platinum Vena Cava Filter |
Inferior vena cava filter |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Filter-related primary endpoint (safety)
時間枠：Index procedure through 12-months post procedure
|
Freedom from major adverse events through 12 months (365 ± 30 days), defined as clinically significant IVC penetration, migration of filter (>2 cm)/filter components, filter fracture, embolization of filter or filter fragments to the heart or lungs, IVC thrombotic occlusion, symptomatic deep vein thrombosis while a filter is indwelling, access site complications with clinical sequelae, and procedure/device-related death. |
Index procedure through 12-months post procedure
|
|
Filter-related primary endpoint (performance)
時間枠：12-months post procedure
|
Performance: Technical placement success and freedom from symptomatic PE while a filter is indwelling through 12 months (365 ± 30 days).These values will be reported as aggregate. Technical placement success - Deployment of filter in a location suitable to provide sufficient mechanical protection against PE with no filter deformation, fracture, premature release, or clinical migration. |
12-months post procedure
|
|
Filter Retrieval-related primary endpoint
時間枠：Through 30-days post procedure
|
Freedom from major adverse events through 30 days post-procedure, defined as access site complications with clinical sequelae, and procedure/device-related death. |
Through 30-days post procedure
|
|
Filter Retrieval-related primary endpoint
時間枠：At the time of retrieval procedure
|
Technical retrieval success, defined as endovascular retrieval of complete filter. |
At the time of retrieval procedure
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- MDR-2126
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request immediately after approval or clearance of the product and ending 5 years after approval or clearance. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。